Using R in a GxP environment (Part 2)

In part two of three of the webinar series Using R in a Gxp Environment, Damian Rodziewics, CEO and founder of Appsilon, Nicolas Masel, Eli Miller, and Jessica Higgins with Johnson & Johnson presented on their experience using R in pharma.

Damian Rodziewics began the presentation by covering GxP, accuracy, distribution, and infrastructure at Appsilon. Afterward, he shares different programming practices along with pointers on reproducibility and traceability. During the second part of the presentation, the team at Johnson & Johnson presented their experiences building a GxP framework with R. Members of the team covered R Package validation, system qualification, risk assessment, and challenges. At the end of the webinar, all members had an open Q&A for the audience to ask questions and clarifications.

Main Sections

0:00 Introduction
3:40 Using R in a GxP environment - Damian Rodziewicz
5:08 GxP - ensuring a safe and reliable product
5:57 Accuracy
7:12 Distribution and infrastructure
8:27 Updating and adjusting
12:51 Programming practices
14:17 Reproducibility
15:02 Traceability
16:52 Experiences building a GxP framework with R - A J&J SDS and C&SP overview
18:16 R Package validation
21:46 System qualification
25:09 R package risk assessment framework
30:26 Challenges
32:51 Q&A
56:27 Closing and thank you!

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